Title (COG ACNS0334) A Phase III Randomized Trial for the Treatment of Newly Diagnosed Supratentorial PNET and High Risk Medulloblastoma in Children < 36 Months Old with Intensive Induction Chemotherapy with Methotrexate Followed by Consolidation with Stem Cell Rescue vs. the Same Therapy Without Methotrexate
Principal Investigator Martin Brecher, MD
Study Number 123707
Summary This is a randomized Phase III trial for children less than 36 months old with high-risk medulloblastoma/PNET. It is designed to determine whether the addition of high dose methotrexate to three cycles of the 4 drug induction backbone (Regimen B) will achieve a higher complete response rate versus three cycles of the 4 drug induction regimen itself (Regimen A). Both of these induction regimens will be followed by three tandem stem cell transplants using the maximum tolerated dose of thiotepa of 10mg/kg/day. After completion of 3 cycles of induction therapy, if complete response has not been attained, then a second surgical attempt at gross total resection is strongly encouraged, if feasible. Although radiation therapy is not a part of this clinical trial, guidelines for radiation therapy are included and the use of radiation therapy should be given serious consideration following the completion of resection.
- Children less than 36 months of age at time of definitive surgery who have high risk Medulloblastoma will be eligible for entry.
- Children less than 36 months of age at the time of definitive surgery with supratentorial PNET (any M stage) will be eligible for study entry
- Children less than 8 months of age at time of definitive surgery with or without measurable radiographic residual tumor with M0 stage Medulloblastoma will be eligible for study entry
- Patients with anaplastic medulloblastoma are eligible regardless of M-stage or residual tumor
- Patients with M0 classic, non-desmoplastic medulloblastoma (R1) with radiographically measurable resdiual disease <1.5cm 2 are eligible
- Cranial MRI (with and without gadolinium) must be done pre-operatively
- Post-operatively, cranial MRI (with and without gadolinium) must be done preferably within 48 hours of surgery. Entire spinal MRI must be obtained either pre-operatively (with gadolinium) or post operatively (at least 10 days follwing surgery) prior to study enrollment (with and without gadolinium)
- Evaluation of lumbar CSF cytology must be performed either pre operatively or at least 10 days after definitive surgery unless contraindicated
- Patients must have a life expectancy of > 8 weeks
- Patients must have received no prior radiation therapy or chemotherapy other than corticosteroids.
- Adequate renal function, adequate liver function, adequate cardiac function, adequate pulmonary function and adequate bone marrow function.